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Trial registered on ANZCTR


Registration number
ACTRN12619001050145
Ethics application status
Approved
Date submitted
16/06/2019
Date registered
25/07/2019
Date last updated
25/07/2019
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
comparison of cellular versus acellular amnion in superficial burns of the face.
Scientific title
Outcome Of Cellular Versus Acellular Amnion In Superficial Facial Burn: A Randomized Trial
Secondary ID [1] 298494 0
Nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn 313277 0
Condition category
Condition code
Skin 311720 311720 0 0
Other skin conditions
Injuries and Accidents 311721 311721 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Amnion will be obtained after informed consent from enrolled healthy expecting mothers undergoing C-section, with no co-morbidities or infections, testing negative for HBV, HCV and HIV. Meconium-contaminated placenta would be discarded. Amnion will be separated from placenta by washing with large volumes of normal saline. Membranes would then be transferred to another container containing 70% glycerol and refrigerated at 4 degree Centigrade.
For Group A, Amnion will be retrieved from the fridge, dipped in normal saline for 10 min to remove glycerol and single layer of amnion will be applied to the cleaned and dried facial burns by the primary investigator, ensuring no air bubbles between it and the bed. Topical antibiotic ointment (Polyfax Ointment - Glaxosmithkline) will be applied three times a day up-to 2 at least 2 weeks up-to 1 month. No secondary dressing will be applied. The amnion will remain there till the burn wound epithelization at least 2 weeks and up to 1 month.
Intervention code [1] 314748 0
Treatment: Other
Comparator / control treatment
In Group B, the Amnion will be initially preserved in glycerol, to make it acellular it will be washed with normal saline, and then will spread it on dried slides. Application of trypsin for at least 20 minutes to detach the epithelial layer, and then gentle scraping to remove the layer. it will be washed again with saline and will be preserved in glycerol at -80C.
For Group B, Amnion will be retrieved from the fridge, dipped in normal saline for 10 min to remove glycerol and single layer of amnion will be applied to the cleaned and dried facial burns by the primary investigator, ensuring no air bubbles between it and the bed. Topical antibiotic ointment (Polyfax Ointment - Glaxosmithkline) will be applied three times a day up-to 2 at least 2 weeks up-to 1 month. No secondary dressing will be applied. The amnion will remain there till the burn wound epithelization at least 2 weeks and up to 1 month.
Control group
Active

Outcomes
Primary outcome [1] 320424 0
Wound healing by complete epithelization assessed clinically by seeing the complete resurfacing of skin by epithelium
Timepoint [1] 320424 0
Patients will be assessed on post-operative day 1, 5, and 10. Finally, the post-operative day on which the dressing spontaneously leaves the donor site, revealing a healed wound, will be noted up to 1 month
Secondary outcome [1] 371555 0
Pain will be measured clinically with visual analog scale for pain from 0-10, where 0 will be no pain and 10 will be worst pain
Timepoint [1] 371555 0
It will be assessed at 24 and 48 hours post operative
Secondary outcome [2] 371556 0
Hypersensitivity, will be assessed clinically by history of itching and presence of redness and swelling on examination
Timepoint [2] 371556 0
Will be assessed at 24 and 48 hours post operative
Secondary outcome [3] 371557 0
Infection will be assessed clinically by history of pain and presence of redness, swelling, raised temperature of surrounding skin on examination
Timepoint [3] 371557 0
will be assessed at one and two week post operative
Secondary outcome [4] 371558 0
Need of skin grafting for non healing burns, will be marked as yes or no. By checking the medical records of skin graft procedure and examining the wound of the patient by consultant plastic surgeon
Timepoint [4] 371558 0
will be assessed at one month post operative

Eligibility
Key inclusion criteria
2nd degree facial burns
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Burn more at 48 hours at presentation
Patients with full thickness facial burns

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a random number table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Safety will be checked by hypersensitivity reaction, pain and infection. While efficacy will be checked by wound healing and neck for skin graft

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21612 0
Pakistan
State/province [1] 21612 0
Punjab

Funding & Sponsors
Funding source category [1] 303039 0
Hospital
Name [1] 303039 0
Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan
Country [1] 303039 0
Pakistan
Primary sponsor type
Individual
Name
Farrukh Aslam Khalid
Address
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 303022 0
None
Name [1] 303022 0
Address [1] 303022 0
Country [1] 303022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303592 0
Ethical Review Committee
Ethics committee address [1] 303592 0
Ethics committee country [1] 303592 0
Pakistan
Date submitted for ethics approval [1] 303592 0
01/09/2018
Approval date [1] 303592 0
03/11/2018
Ethics approval number [1] 303592 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94186 0
Dr Mehwish Ihsan Butt
Address 94186 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 94186 0
Pakistan
Phone 94186 0
+923234442933
Fax 94186 0
Email 94186 0
mehwish_baka@hotmail.com
Contact person for public queries
Name 94187 0
Farrukh A Khalid
Address 94187 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 94187 0
Pakistan
Phone 94187 0
+923009671600
Fax 94187 0
Email 94187 0
drfarrukhaslam@gmail.com
Contact person for scientific queries
Name 94188 0
Mehwish Ihsan Butt
Address 94188 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 94188 0
Pakistan
Phone 94188 0
+923234442933
Fax 94188 0
Email 94188 0
mehwish_baka@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be stored confidentially and will not be used for any further research unless further ethics approval is granted.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.